Japan's MHLW to review 3 drugs, 2 devices for Sakigake list

Japan's Ministry of Health, Labor and Welfare (MHLW) will review another 5 candidates for its fast-track approval process known as Sakigake, all of which started as academic work and include two medical devices.

A MHLW spokesman said three of the products are regenerative medicine candidates that includes a gene therapy backed by Tokyo-based Daiichi Sankyo and developed at the University of Tokyo's Institute of Medical Science dubbed G47Δ to treat brain tumors and in Phase II trials.

Japan Health Minister Yasuhisa Shiozaki

As well, Osaka-based Nipro won a nod for a potential stem cell treatment for spinal cord injuries, STR01. Also in the regenerative medicine field was an unspecified candidate using autologous cardiac stem cells to treat heart disease in children.

On the medical device side, Tokyo-based Otsuka Pharmaceutical's resorbable barrier to curb the risk of organ adhesion after surgery was approved and a titanium bridge from Tokyo-based Nobelpharma to protect vocal chords.

In October, MHLW named six drugs under the Sakigake fast-track review process launched in April of 2015, including Merck's ($MRK) Keytruda.

Any products considered must display a novel mechanism of action, be scalable commercially, show high efficacy and be developed and planned for approval in Japan ahead of the rest of the world, MHLW's Pharmaceutical and Medical Devices Agency (PMDA) said in April.

- here's the release from Nipro (Japanese language)
- and the release from Daiichi Sankyo
- for the MHLW website